BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLA SET SCW HEXDRIVER

    MDR report key: 4614022 · Received March 18, 2015

    Report

    Report Number
    1526439-2015-10192
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    February 23, 2015
    Report Date
    February 23, 2015
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HWC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATES: DEC 28, 2001 AND MAR 21, 2002 VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED A FRACTURE WAS LOCATED AT THE DRIVER¿S DISTAL TIP. THE DEVICE WAS THEN SENT FOR FRACTURE ANALYSIS. THE FRACTURE ANALYSIS REPORT INDICATED THAT THE FRACTURED SURFACE REVEALS MINIMAL PLASTIC DEFORMATION ACROSS THE ENTIRE SURFACE SUGGESTING A STATIC OVERLOAD FAILURE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A TREND ANALYSIS WAS CONDUCTED. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE OF THE HEXDRIVER TIP BECOMING BROKEN CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE FRACTURE ANALYSIS REPORT INDICATED THAT THE FRACTURED SURFACE REVEALS MINIMAL PLASTIC DEFORMATION ACROSS THE ENTIRE SURFACE SUGGESTING A STATIC OVERLOAD FAILURE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS WERE FOUND, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    SURGEON WAS IN THE PROCESS OF REMOVING PREVIOUSLY INSERTED SPINE IMPLANTS. TIP OF SCREWDRIVER BROKE. TIP OF SCREWDRIVER RETRIEVED. DEVICE WILL BE FORWARDED ON RECEIPT. COMPLETED WITH SAME / LIKE PRODUCT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185080 ISOLA SET SCW HEXDRIVER WRENCH HWC DEPUY SYNTHES SPINE 1201V

    Patients

    Seq Age Sex Outcome Treatment
    1